InPOG-HL-15-01 - Challenges and lessons learnt in setting up the first collaborative multicentre prospective clinical trial in childhood cancer in India

Arora, Ramandeep Singh; Mahajan, Amita; Dinand, Véronique; Kalra, Manas; Jain, Sandeep; Taluja, Ankit; Mandal, Piali; Chandra, Jagdish

doi:10.1016/j.phoj.2020.02.001

Cited by 10 publications

(7 citation statements)

References 10 publications

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“…120,121 A preliminary report from the InPOG HL trial described the process of creating a risk-stratified treatment protocol that could be feasibly executed at 27 participating centers across India and the challenges of implementing a multicenter clinical trial for the first time. 122 InPOG is planning two additional prospective HL clinical trials 122 and has also opened a multicenter randomized trial in ALL that is currently enrolling. 123 InPOG has also collaborated with the Indian Pediatric Oncology Initiative to create the India Pediatric Oncology Database, a web-based database to facilitate hospital-based cancer registries and clinical trial research.…”

Section: Methodsmentioning

confidence: 99%

Mapping Pediatric Oncology Clinical Trial Collaborative Groups on the Global Stage

Major

Palese

Ermis

et al. 2022

JCO Global Oncology

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PURPOSE The global pediatric oncology clinical research landscape, particularly in Central and South America, Africa, and Asia, which bear the highest burden of global childhood cancer cases, is less characterized in the literature. Review of how existing pediatric cancer clinical trial groups internationally have been formed and how their research goals have been pursued is critical for building global collaborative research and data-sharing efforts, in line with the WHO Global Initiative for Childhood Cancer. METHODS A narrative literature review of collaborative groups performing pediatric cancer clinical research in each continent was conducted. An inventory of research groups was assembled and reviewed by current pediatric cancer regional and continental leaders. Each group was narratively described with identification of common structural and research themes among consortia. RESULTS There is wide variability in the structure, history, and goals of pediatric cancer clinical trial collaborative groups internationally. Several continental regions have longstanding endogenously-formed clinical trial groups that have developed and published numerous adapted treatment regimens to improve outcomes, whereas other regions have consortia focused on developing foundational database registry infrastructure supported by large multinational organizations or twinning relationships. CONCLUSION There cannot be a one-size-fits-all approach to increasing collaboration between international pediatric cancer clinical trial groups, as this requires a nuanced understanding of local stakeholders and resources necessary to form partnerships. Needs assessments, performed either by local consortia or in conjunction with international partners, have generated productive clinical trial infrastructure. To achieve the goals of the Global Initiative for Childhood Cancer, global partnerships must be sufficiently granular to account for the distinct needs of each collaborating group and should incorporate grassroots approaches, robust twinning relationships, and implementation science.

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Section: Methodsmentioning

confidence: 99%

Mapping Pediatric Oncology Clinical Trial Collaborative Groups on the Global Stage

Major

Palese

Ermis

et al. 2022

JCO Global Oncology

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“…Indian pediatric oncology group (InPOG), a research/clinical trial division of Pediatric Hematology Oncology Chapter of Indian Academy of Pediatrics, established disease‐specific research groups in 2015 3 . With the specific mandate of promoting collaborative clinical research, InPOG‐HL‐15‐01 was the first multicenter study that recruited patients from 27 hospitals across India for a uniform risk‐adapted and response‐based management of childhood HL 4 . The study utilized ABVD regimen (doxorubicin, bleomycin, vinblastine, dacarbazine) and stratified patients into early and advanced stage disease.…”

Section: Introductionmentioning

confidence: 99%

“…3 With the specific mandate of promoting collaborative clinical research, InPOG-HL-15-01 was the first multicenter study that recruited patients from 27 hospitals across India for a uniform risk-adapted and response-based management of childhood HL. 4 The study utilized ABVD regimen (doxorubicin, bleomycin, vinblastine, dacarbazine) and stratified patients into early and advanced stage disease. RT was delivered to children with suboptimal response at early response assessment (ERA) or those with bulky disease.…”

Section: Introductionmentioning

confidence: 99%

Response assessment by positron emission tomography‐computed tomography as compared with contrast‐enhanced computed tomography in childhood Hodgkin lymphoma can reduce the need for radiotherapy in low‐ and middle‐income countries

Kalra

Bakhshi

Singh

et al. 2022

Pediatric Blood & Cancer

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Introduction The InPOG‐HL‐15‐01, a multicentric prospective study, used a risk‐stratified and response‐based approach with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) backbone to treat children and adolescents with newly diagnosed Hodgkin lymphoma (HL) and reduce the use of radiation therapy (RT). Children/adolescents with bulky disease or inadequate response at early response assessment (ERA) after two cycles of chemotherapy were assigned to receive RT. For ERA, positron emission tomography computed tomography (PET‐CT) was recommended but not mandatory in view of limited access. This study aimed to compare the impact of using contrast‐enhanced computed tomography (CECT) and PET‐CT on treatment decisions and outcomes. Methodology 396 patients were enrolled and 382 had an ERA at the assigned time point. Satisfactory response was defined as Deauville score 3 or less for patients undergoing PET‐CT and complete response (CR)/very good partial response (VGPR) for patients undergoing CECT. Outcomes of interest incorporate 5 year event‐free survival (EFS), EFS including abandonment (EFSa), and overall survival (OS). Results At ERA, satisfactory response was documented in 277 out of 382 (72.5%) participants and this was significantly higher in PET‐CT (151 out of 186, 81.2%) as compared with CECT‐based assessments (126 out of 196, 64.3%) respectively (p value < .001). Amongst the 203 patients with nonbulky disease (wherein the indication for RT was entirely dependent on ERA), 96 out of 114 (84.2%) and 61 out of 89 (68.5%) patients achieved a satisfactory response according to the PET‐CT and CECT (p value = .008) respectively and hence a lesser proportion of patients in the PET‐CT arm received RT. Despite a lower usage of RT the 5 year OS of both groups, ERA based on CECT (91.8%) versus PET‐CT (94.1%) was comparable (p value = .391) and so was the 5 year EFS (86.7 vs. 85.5%, p value = .724). Conclusion Use of PET‐CT as the modality for ERA is more likely to indicate a satisfactory response as compared with CECT and thereby decreases the need for RT in response‐based treatment algorithm for HL‐afflicted children. The reduction in the application of RT did not impact the overall outcome and plausibly would lower the risk of delayed toxic effects.

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“…Collaborative, prospective research effort is only just beginning in India with the Indian Pediatric Oncology Group (InPOG) providing a platform for multicenter co‐operative clinical studies 8 . InPOG‐HL‐15‐01, a multicenter prospective study aimed at describing the epidemiology and outcomes of children with HL treated in a risk‐stratified, response‐adapted fashion using an ABVD backbone is amongst the first studies in the InPOG portfolio 9 …”

Section: Introductionmentioning

confidence: 99%

“…8 InPOG-HL-15-01, a multicenter prospective study aimed at describing the epidemiology and outcomes of children with HL treated in a risk-stratified, response-adapted fashion using an ABVD backbone is amongst the first studies in the InPOG portfolio. 9 The primary aim of this study was to evaluate whether limited cycles of this simple regimen and RT restricted only to patients with bulky disease or those with suboptimal response at ERA after two cycles of chemotherapy can deliver satisfactory outcomes in early-stage disease in resource-limited settings. While limiting the number of cycles for early-stage disease has been evaluated for other chemotherapy regimens, this has not been formally evaluated on an ABVD backbone.…”

Section: Introductionmentioning

confidence: 99%

Treating early‐stage Hodgkin lymphoma in resource‐limited settings: InPOG‐HL‐15‐01 experience

Mahajan

Singh

Bakhshi

et al. 2021

Pediatric Blood & Cancer

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Background Hodgkin lymphoma (HL) in childhood is an eminently curable disease. Excellent outcomes can be achieved even in resource‐limited settings and increasingly, the focus is on limiting long‐term toxicity. Contemporary treatment incorporates a risk‐stratified, response‐adapted approach using multiagent chemotherapy with or without low‐dose radiotherapy (RT). Many developing countries continue to use ABVD (adriamycin, bleomycin, vinblastin, and dacarbazine)‐based regimen owing to limited acute toxicity, cost, and ease of delivery. We report outcomes of children with early‐stage HL using limited cycles of ABVD‐based treatment in the first prospective multicentric collaborative study from India InPOG‐HL‐15‐01. Methods Children <18 years with biopsy‐proven HL were enrolled. Patients with stages I and IIA with or without bulky disease were classified as having early‐stage disease. Patients were planned to receive four cycles of ABVD subject to satisfactory early response assessment (ERA) scheduled after two cycles of chemotherapy. RT was limited to patients with bulky disease or those with suboptimal ERA. Results Four hundred ten patients were enrolled over 30 months from 27 centers. One hundred thirty‐four were classified as having early‐stage disease. Fifty‐three (40%) of these had bulky disease. One hundred ten (83%) of this cohort achieved complete or very good partial ERA. Fifty‐four (40%) received RT. At a median of 52 months since diagnosis, 5‐year event‐free survival (EFS) and overall survival (OS) is 94% and 95.5%, respectively. Treatment‐related mortality and abandonment were <1%. Conclusion Limited cycles of ABVD with RT to selected patients is a very effective option for patients with early‐stage disease in resource‐limited settings.

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InPOG-HL-15-01 - Challenges and lessons learnt in setting up the first collaborative multicentre prospective clinical trial in childhood cancer in India

Cited by 10 publications

References 10 publications

Mapping Pediatric Oncology Clinical Trial Collaborative Groups on the Global Stage

Mapping Pediatric Oncology Clinical Trial Collaborative Groups on the Global Stage

Response assessment by positron emission tomography‐computed tomography as compared with contrast‐enhanced computed tomography in childhood Hodgkin lymphoma can reduce the need for radiotherapy in low‐ and middle‐income countries

Treating early‐stage Hodgkin lymphoma in resource‐limited settings: InPOG‐HL‐15‐01 experience

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